The following data is part of a premarket notification filed by Truphatek, Ltd. with the FDA for Otoscope.
| Device ID | K902205 |
| 510k Number | K902205 |
| Device Name: | OTOSCOPE |
| Classification | Otoscope |
| Applicant | TRUPHATEK, LTD. P.O. BOX 8051 Netanya, IL 42106 |
| Contact | David Grey |
| Correspondent | David Grey TRUPHATEK, LTD. P.O. BOX 8051 Netanya, IL 42106 |
| Product Code | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-16 |
| Decision Date | 1990-08-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OTOSCOPE 77875618 3905524 Live/Registered |
Smith, Richard J.H. 2009-11-18 |